P1a patient population heavily pretreated, probably with...

P1a patient population heavily pretreated, probably with anthracyclines, and too sick. You have to remember that a patient needs to be able to perform two VO2peak tests. Yes, they may be able to get some biomarker data, though I am unsure how impactful this will be. I assume P1a will escalate Bisantrene dose on a backdrop of standardised Doxorubicin dosing.

P1b patient population anthracycline naive and able to perform the required physical testing.

Not related to what you are saying, JP, though it is perfectly reasonable that the first ever CPACS trial requires additional time to review ethics and governance. Being at the forefront of drug development for truly novel compounds means accepting that there will be factors beyond the usual path, outside of our awareness and control.

For example, since this Phase 1a/b trial combines anti-cancer and cardiovascular elements, ethics and governance review must involve input from both oncology and cardiology departments. This kind of trial has never been done before, so the specialists are seeing this for the first time, which may naturally extend the review time. It’s just one example of why trailblazing requires extra time.